NCT00195481

Brief Summary

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

Enrollment Period

1.7 years

First QC Date

September 12, 2005

Last Update Submit

December 21, 2007

Conditions

Kidney FailureGraft vs Host Disease

Keywords

KidneyTransplant

Outcome Measures

Primary Outcomes (1)

  • Safety evaluation

Interventions

RapamuneDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
  • Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

You may not qualify if:

  • Evidence of major infections at the time of sirolimus administration
  • Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
  • Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Bangalore, Karnataka, 566 006, India

Location

Unknown Facility

Bangalore, Karnataka, 566 018, India

Location

Unknown Facility

Saket, South Delhi, India

Location

Unknown Facility

Chennai, Tamil Nadu, 600 004, India

Location

Unknown Facility

New Delhi, India

Location

MeSH Terms

Conditions

Renal InsufficiencyGraft vs Host Disease

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

IN(5)